During surgical procedures there is a need to maintain a sterile field around the surgical wound site. A surgical drape is a tool that helps to create and maintain the sterile surgical field by creating a physical barrier between the sterile field and the non-sterile field that minimizes the passage of microorganisms between the sterile field and non-sterile areas outside of the field. Maintaining sterility in the surgical field typically requires that instruments that are used in the field are sterilized before they are introduced into the field. However, some devices that are used during surgical procedures are not easily sterilized; such devices are therefore draped or covered with sterile protective covers—surgical drapes. Often these covers are disposable.
An example of a device used during surgery that does not lend itself to sterilization is a limb positioning tool. These devices help the surgical team position a patient's limb during surgery but given their bulkiness cannot be easily sterilized using standard sterilization equipment and techniques. For example, during many orthopedic surgical procedures such as shoulder surgery the patient's arm and shoulder must be positioned and repositioned to provide the surgical team with adequate access to the surgical site. Limb positioning devices make the job of limb positioning and adjustment relatively easy. However, the positioning devices can be bulky, and hence surgical drapes are used to cover the limb positioner and isolate the sterile wound site from the equipment.
There are numerous types of positioning tools and most are adapted to be connected to or closely associated with an operating room table. An electrically operated positioning tool has an extension that attaches to and which supports a patient's limb or other portion of the patient either directly or with an accessory specifically designed to engage the patient. The electrical positioning tool allows the surgical staff to manipulate and orientate both the patient's limb and surgical implements during the procedure in what are known as interpretive movements. Often during surgical procedures the surgical staff will perform numerous interpretive movements. In order for the draped positioning device to perform its function, some form of communication is required from the surgeon or other member of the surgical team, who is in the sterile surgical field, to the positioning device, which is outside of the sterile field by virtue of the drape isolating the device. This communication between surgical staff and the positioning device often involves the use of switches, levers, knobs and buttons of various descriptions—all of which are referred to herein for ease of reference as “control surfaces.” These control surfaces are located outside of the sterile field and must be accessed and manipulated through the drape material. In other words, a member of the surgical team must actuate the control surface with the surgical drape positioned between the team member's hand and the control surface in order to maintain the sterile field. Activating control surfaces such as switches, levers and knobs can be quite difficult when performed through a sterile drape.
In addition, the risk of tearing the surgical drape and compromising the sterile field increases with repeated access to the control surface. Thus, as the surgical team performs more interpretive movements, there is a risk of tearing the surgical drape. Moreover, because the surgical drape necessarily defines a barrier between the surgical team and the control surface, that barrier that can obstruct the appearance and feel of the control surface. This can result in an unintentional movement of the positioning device that may compromise the surgical procedure.
Some positioning equipment, particularly electrically operated equipment, has control surfaces that are located in positions that are remote from the operative end of the equipment that engages the patient and thus do not interfere with the range of motion of the device. These kinds of equipment may be activated without the team member accessing the control surface through the drape. For example, some equipment have control surfaces such as foot pedals that when depressed activate the positioner, which allow a full range of motion during set up of the equipment and prevent entanglement or wind up of associated wires or tubes that are needed to communicated between the control surface and the positioning equipment. However, a remotely located control surface such as a foot pedal is not ideal for the surgical team because it requires manipulation from a position that is removed from the surgical site and necessarily requires that the team member's attention is directed elsewhere, away from the surgical site to the remote actuator. This is a distraction that can cause problems during the surgical procedure, and at a minimum is an unnecessary distraction.
There are distinct advantages to having the ability to locate the control surface for a positioning device to a position that is convenient to the surgeon. The location could be on the patient, a secondary drape, a piece of related equipment or near such equipment, or anywhere within the surgical field that is convenient. Because there are a variety of different kinds of positioning equipment and because some positioning equipment may be used for multiple positioning challenges, the ideal location for a control surface would be changeable from procedure to procedure, application to application, as well as to satisfy the preference of each surgeon. Thus, the optimal location of a control surface is variable within the surgical field and depends upon the particular equipment being controlled, the procedure being performed and the particular surgeon's preference.
Accordingly, there is a need for a sterile barrier adapted to incorporate a mechanism for controlling surgical equipment that addresses these and other concerns.
The present invention defines a surgical drape with a control surface integrated therein that meets these and other needs. The invention provides an improved sterile disposable drape incorporating a control mechanism that is in the sterile field and that allows for actuation and greater control of positioning equipment, overcoming many of the deficiencies of known devices. A disposable sterile drape according to the present invention has an integrated sterile control surface located on an outer surface of the drape to protect against compromising the sterile field. The entire drape, including the integrated control surface is disposable. By positioning the control surface on an outer surface of the drape, risk that damage to the drape will occur during surgical interpretive movements, with associated compromise of the sterile barrier is greatly reduced in comparison to the situation where the control surface must be manipulated through the drape. The location of the control surface on the outside of the drape reduces the chance of accidental or undesired activation of the positioning device that is activated by the control surface due to confusion caused by the drape obstructing the surgeon's view of the control surfaces beneath the drape. With the control surface mounted in plain view on the sterile side of the drape, the control mechanisms are easily visible and easily activated, preventing undesired activation.
The invention defines a disposable sterile drape having an integrated sterile disposable control surface on the outside of the drape that locates the control surface for improved tactile feel of the user. The location of the control surface can be changed within the sterile field so that the surgeon may select a position for the control surface that is advantageous for a particular piece of electrical positioning equipment or which otherwise satisfies the surgeon. The positioning of the control surface may be improved by moving it to a location closer to the operative end of the equipment that is activated by the control surface. Once the positioning device is set up for a surgical procedure and the need for large range patient motions have been completed, the drape and the control surface may be used to cover the positioning device to establish a sterile field around the device. Moreover, once set up is performed, the range of motion of the positioning equipment is typically limited; the control surface located on an outer surface of the drape provides for sufficient mobility to allow all needed motion while placing the activation mechanism in a desired location.
The present invention defines a disposable sterile drape having an integrated sterile disposable control surface on an outer surface of the drape that can be relocated within the sterile field to an area other than the drape, such as a patient surface, secondary drape or accessory equipment. The control surface defines apparatus for controlling positioning equipment and it may be removed from its location on the outer surface of the drape and placed through the use of an adhesive or another attachment means to a location anywhere within the sterile field, limited only by the length or the range of transmission of the communication interface element that extends from the activation element.
The disposable sterile drape according to the invention may be used with numerous different types of positioning equipment used in surgical procedures, including for example limb positioners and operating room tables. The invention may further be used with surgical tools such as various scoping instruments, retractors and the like.
These and other advantages of the invention described herein and defined by the appended claims will be evident from review of the following description and drawings.